A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Expanded access is currently available for this treatment.
Verified November 2015 by Stanford University
BTG International Inc.
Information provided by (Responsible Party):
Daniel Yung-Ho Sze, Stanford University
ClinicalTrials.gov Identifier:
First received: February 24, 2010
Last updated: November 16, 2015
Last verified: November 2015
To provide Therasphere treatment for patients diagnosed with unresectable liver cancer.

Condition Intervention
Liver Cancer
Device: Theraspheres

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Humanitarian Device Exemption Treatment Protocol of TheraSphere For Treatment of Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by Stanford University:

Study Start Date: December 2008
Estimated Study Completion Date: December 2099
Estimated Primary Completion Date: December 2099 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Theraspheres
    Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.
    Other Names:
    • HCC
    • hepatocellular carcinoma treatment

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients over 18 years of age, of any race or sex, who have hepatocellular carcinoma of the liver, and who are able to give informed consent, will be eligible. Patients must have an ECOG Performance Status score of £ 2, with a life expectancy of >= 3 months, non-pregnant with an acceptable contraception in premenopausal women. Patients must be >4 weeks since prior radiation or prior surgery and at least 1 month post other chemotherapy.

Exclusion Criteria:

  • Contraindications to angiography and selective visceral catheterization
  • Evidence of potential delivery of greater than 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs
  • Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (ex. placing catheter distal to gastric vessels)
  • Significant extrahepatic disease representing an imminent life-threatening outcome
  • Severe liver dysfunction or pulmonary insufficiency
  • Active uncontrolled infection
  • Significant underlying medical or psychiatric illness
  • Pregnancy

Patients will be excluded: if they have pre-existing diarrhea/illness, or if they have a co-morbid disease or condition that would preclude safe delivery of TheraSphere treatment and place the patient at undue risk.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01076517

Contact: Danielle Katz 650-723-0728 dkatz@stanfordhealthcare.org

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Contact: Danielle Katz    650-723-0728    dkatz@stanfordhealthcare.org   
Principal Investigator: Daniel Y Sze, MD PhD         
Sub-Investigator: John D Louie, MD         
Sub-Investigator: Nishita Kothary, MD         
Sponsors and Collaborators
Stanford University
BTG International Inc.
Principal Investigator: Daniel Yung-Ho Sze Stanford University
  More Information

Responsible Party: Daniel Yung-Ho Sze, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01076517     History of Changes
Other Study ID Numbers: XHEP0016-NOT-RESEARCH  HEP0016  14324 
Study First Received: February 24, 2010
Last Updated: November 16, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on April 27, 2016